Terrasil Rapid-relief Vaginal
FDA Label NDC 24909-162

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aidance Skincare & Topical Solutions, Llc for the product Terrasil Rapid-relief Vaginal (NDC 24909-162). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children., directions, inactive ingredients, principal display panel - box, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Miconazole Nitrate 2%

Purpose

Vaginal Antifungal

Uses

Treats vaginal yeast infections.

Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

Ask a doctor before use if you have
● vaginal itching and discomfort for the first time
● lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling
vaginal discharge. You may have a more serious condition.
● vaginal yeast infections often (such as once a month or 3 in 6 months).
You could be pregnant or have a serious underlying medical cause for your
symptoms, including diabetes or a weakened immune system.
● been exposed to human immunedeficiency virus (HIV) that causes AIDS.

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine
warfarin, because bleeding or bruising may occur.

When using this product
● do not use tampons, douches, spermicides, or other vaginal products.
Condoms and diaphragms may be damaged and fail to prevent pregnancy
or sexually transmitted disease (STDs).
● do not have vaginal intercourse
● mild increase in vaginal burning, itching, or irritation may occur
● if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if
● symptoms do not get better after 3 days
● symptoms last more than 7 days
● you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.

If pregnant or breast feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Children under 12: Ask a doctor.
Adults and children 12 years and over:
Ointment: May be used topically (outside the vaginal area) or intravaginally.
Squeeze a small amount of ointment onto fingertip.
Apply 2-3 times daily for up to 3 days or longer, as needed. May stain fabrics.
Cleansing Bar: Wash affected areadaily. Store at room temperature.

Inactive Ingredients

Ointment: beeswax (organic), bentonite (volcanic clay), jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, tea tree oil, zinc oxide.

Cleansing Bar: beeswax, bentonite clay, coconut oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, tea tree oil, titanium dioxide, tetrasodium etidronate, zinc oxide.

Principal Display Panel - Box

Vaginal Discomfort

  • Vaginal Itch
  • Odor and Discharge
  • Yeast Infection and Vaginitis

    • All Natural

    terrasil

    RAPID-RELIEF VAGINAL OINTMENT

    Plus Medicated Cleansing Bar

    2.5X FASTER

    compared to leading brands
    in scientific studies

    THE END OF SUFFERING

    Healing and Relief Since 2004

    Box (Terrasil Rrv Kit Reg 25g 031014)

    Box (Terrasil Rrv Kit Reg 25g 031014)

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